Retrospective Multicenter Comparison Between Viabahn Covered Stent-Grafts and Supera Interwoven Nitinol Stents for Endovascular Treatment in Severely Calcified Femoropopliteal Artery Disease: The ARMADILLO Study (Adjusted Retrospective coMparison of scAffolDs In caLcified LesiOns).

ABSTRACT

PURPOSE: The previous single-arm registries showed the acceptable primary patency after endovascular therapy (EVT) using covered stent-graft (CSG) and Supera interwoven nitinol stent (Supera peripheral stent [SPS]) in calcified femoropopliteal lesions. The aim of this study was to compare the safety and efficacy between CSG and SPS in calcified femoropopliteal lesions in clinical practice. MATERIALS AND METHODS: We retrospectively analyzed 341 cases who had Rutherford class 2 to 6 peripheral artery disease and underwent EVT with either CSG (n=137) or SPS (n=204) for femoropopliteal lesions with bilateral calcification in fluoroscopic image, based on the Peripheral Arterial Calcium Scoring System (PACSS) classification, between April 2017 and February 2021 at 7 cardiovascular centers in Japan. RESULTS: After propensity score (PS) matching, the final study population consisted of 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between CSG and SPS groups (81.4% vs 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The stratification analysis demonstrated that advanced age, current smoking, diabetes mellitus, and PACSS grade 4 had a significant interaction on the association of CSG versus SPS implantation with restenosis (interaction p<0.05). CONCLUSIONS: In patients with bilaterally calcified femoropopliteal lesions, 1-year primary patency was not significantly different between treatments using CSG and SPS after the PS matching. CLINICAL IMPACT Covered stent-graft (CSG) and Supera interwoven nitinol stent (SPS) are reliable endovascular devices in calcified femoropopliteal lesions. This retrospective multicenter study compared the clinical outcomes between the two devices. After propensity score matching, 150 matched patients with no remarkable intergroup difference in baseline characteristics. The primary patency at 1 year was not statistically different between the CSG and SPS group (81.4% vs. 71.2%, p=0.32). There was also no significant difference in freedom from target lesion revascularization (82.8% vs. 77.6%, p=0.28) and overall survival rate (88.6% vs 87.2%, p=0.81). The two devices showed the similar efficacy in calcified femoropopliteal lesions.